title: Prospective clinical trial on dosage optimizing of tranexamic acid in non-emergency cardiac surgery procedures.
abstract: After withdrawal of aprotinin in 2008 only tranexamic acid (TxA, Cyclocapron, Pfitzer, Germany) remains available as antihyperfibrinolytic agent in Europe. Dosage (from 1 g to 20 g) and application strategy (single shot i.v., infusion i.v., topical) reflect an indiscriminate use of TXA in cardiac surgery. We use data analysis of three registries to evaluate safety issues and sufficiency of different TxA dosages in our center.
  
  
  METHODS
  Registry 1: Single shot ultra-low dose TxA (1 g in priming volume). Registry 2: Single shot medium dose TxA (5 g in priming volume). Registry 3: Single shot medium dose TxA (3 g in priming volume) and continuous, weight-adapted administration during cross clamping. Independence of surgeon's preference was achieved by changing dosage every surgery day regardless of operation schedule.
  
  
  RESULTS
  Data analysis was carried out on 1182 consecutive, elective patients (1 g TxA n = 415; 3 g + x g TA n = 367; mean TxA dose 4.4 g ± 1.0 g; 5 g TxA n = 400). Patient characteristics were well matched in all three registries (mean age: 69 ± 9.5y, BMI 28.2 ± 4.7, Creatinin 107.5 ± 52.8 μM), as were performed surgical procedures (excluding organ transplantation). Postoperative data showed no significant differences for blood loss and major adverse events (1 g vs. 3 + g vs. 5 g: blood loss: 894 ± 1479 vs. 903 ± 1282 vs. 1004 ± 1604 ml; stroke: 1.5 vs. 1.6 vs. 1.5%; myocardial infarction 2.7 vs. 3.3 vs. 1.3%; 30d mortality 3.9 vs. 4.2 vs. 4.8%, respectively). Secondary endpoints (de novo dialysis, transfusion requirement, ICU and total treatment time) showed no significant differences between registries.
  
  
  CONCLUSIONS
  Use of 1 g TxA is safe and sufficient for elective patients with on pump cardiac surgery and thus has been established as strategy of choice in our center.
authors.affiliation: Department of Cardiac Surgery, Herzzentrum Dresden Universitätsklinik an der TU Dresden, Dresden, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Waldow
authors.affiliation: Department of Cardiac Surgery, Herzzentrum Dresden Universitätsklinik an der TU Dresden, Dresden, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Szlapka
authors.affiliation: Department of Cardiac Surgery, Herzzentrum Dresden Universitätsklinik an der TU Dresden, Dresden, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Haferkorn
authors.affiliation: Department of Cardiac Surgery, Herzzentrum Dresden Universitätsklinik an der TU Dresden, Dresden, Germany.
authors.forename: L
authors.initials: L
authors.lastname: Bürger
authors.affiliation: Department of Cardiac Surgery, Herzzentrum Dresden Universitätsklinik an der TU Dresden, Dresden, Germany.
authors.forename: K
authors.initials: K
authors.lastname: Plötze
authors.affiliation: Department of Cardiac Surgery, Herzzentrum Dresden Universitätsklinik an der TU Dresden, Dresden, Germany.
authors.forename: K
authors.initials: K
authors.lastname: Matschke
mesh_terms: D000368:Aged; D000933:Antifibrinolytic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006348:Cardiac Surgical Procedures / Q000379:methods*; D015331:Cohort Studies; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D011446:Prospective Studies; D014148:Tranexamic Acid / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000933:Antifibrinolytic Agents; D014148:Tranexamic Acid